| Trial ID: | L5698 |
| Source ID: | NCT02669732
|
| Associated Drug: |
Ds-8500a
|
| Title: |
An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: DS-8500a|DRUG: placebo
|
| Outcome Measures: |
Primary: First-phase and Second-phase secretion Insulin, First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2), Baseline to Day 28 (Period 1 and 2)|First-phase and Second-phase secretion C-peptide, First-phase and Second-phase secretion (C-peptide), Baseline to Day 28 (Period 1 and 2) | Secondary: M value, M value：Mean of Glucose Infusion Rate from 90 to 120 min, Baseline to Day 28 (Period 1 and 2)|M/I value, M/I value：M value / steady-state Insulin, Baseline to Day 28 (Period 1 and 2)|Disposition Index, Disposition Index：Product of M value and First-phase secretion, Baseline to Day 28 (Period 1 and 2)|Number and severity of Adverse Events, Day 28 (Period 1 and 2)|plasma concentration of DS-8500a, Day 28 (Period 1 and 2)
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-01
|
| Completion Date: |
2016-10
|
| Results First Posted: |
|
| Last Update Posted: |
2019-02-12
|
| Locations: |
SOUSEIKAI Hakata Clinic, Hakata-ku, Fukuoka, 812-0025, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02669732
|
